K082206 is an FDA 510(k) clearance for the BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES. This device is classified as a Prosthesis, Laryngeal (taub) (Class II - Special Controls, product code EWL).
Submitted by Helix Medical, LLC (Carpinteria, US). The FDA issued a Cleared decision on September 4, 2008, 30 days after receiving the submission on August 5, 2008.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3730.
| 510(k) Number | K082206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2008 |
| Decision Date | September 04, 2008 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWL — Prosthesis, Laryngeal (taub) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3730 |